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[唤醒试验:研究有效性、信息与后勤保障。初步结果。质量指标]

[REVEIL Trial: Study validity, information and logistics. Preliminary results. Quality measures].

作者信息

Démolis P, Antony I, Asmar R, Carette B, Vaïsse B

机构信息

Unité de recherche clinique, hôpital Bicêtre, Le Kremlin-Bicêtre.

出版信息

Arch Mal Coeur Vaiss. 2001 Aug;94(8):901-5.

PMID:11575228
Abstract

Self blood pressure measurement (SBPM) is not fully applied because of the cost of devices and the lack of efficient dedicated medical networks. The aim of the REVEIL study was to allow patients to freely rent SBPM devices by their pharmacist after initial medical prescription. Practitioners taught SBPM methods to the patients with a booklet and the pharmacist explained them how to use the device. This preliminary report focuses on the 428 first patients included from September 1999 to June 2000 by their general practitioner (n = 59) or cardiologist (n = 12) in the centre of the city of Reims (France), when he thought there was an indication for a SBPM period. The patient received a medical prescription and took a validated device (Omron 705CP) by one of the 44 pharmacists who accepted to participate. After 7 days the patient consulted his practitioner with the filled booklet. The prescription was for 7 days with 3 measurements each morning (before intake of antihypertensive drugs) and each evening (12 hours later). Patients reported the results on the booklet and enclosed the report printed by the device. From the 428 included patients, 362 (85%) gave analyzable data, the difference being explained by refusals (n = 39) and by the lag between inclusion and completion. Mean age was 55.2 (range 20 to 90). Education levels were: no graduation (n = 71), primary school (n = 172), college (n = 59), university (n = 86) [no answer in n = 40]. Seventy nine percent (n = 286) performed at least 12 measurements on three consecutive days. There is no significant difference between morning and evening completions. According to themselves, 294 patients fully succeeded in SBPM. Eighteen failed (6 reported a failure of the device, 2 had not understood the procedure, 5 had forgotten, 5 reported another cause), 50 did not answer. These results establish the fair applicability of SBPM under the realistic conditions of the REVEIL study (free rent of devices after medical prescription) as 85% of patients gave contributive information with a good quality in 79% of them.

摘要

由于设备成本和缺乏高效的专业医疗网络,自我血压测量(SBPM)尚未得到充分应用。REVEIL研究的目的是让患者在获得初始医疗处方后,能够通过药剂师免费租用SBPM设备。医生用一本手册向患者传授SBPM方法,药剂师向患者解释如何使用该设备。本初步报告聚焦于1999年9月至2000年6月期间,由法国兰斯市中心的全科医生(n = 59)或心脏病专家(n = 12)纳入的首批428例患者,纳入标准为医生认为有进行SBPM阶段的指征。患者获得一份医疗处方,并从44名同意参与的药剂师处领取一台经过验证的设备(欧姆龙705CP)。7天后,患者带着填写好的手册咨询其医生。处方为期7天,每天早晨(服用降压药前)和晚上(12小时后)各测量3次。患者在手册上报告测量结果,并附上设备打印的报告。在428例纳入患者中,362例(85%)提供了可分析的数据,差异原因包括拒绝参与(n = 39)以及纳入与完成测量之间的时间间隔。平均年龄为55.2岁(范围20至90岁)。教育水平分布为:未毕业(n = 71)、小学(n = 172)、中学(n = 59)、大学(n = 86)[40例未作答]。79%(n = 286)的患者连续三天至少进行了12次测量。早晚测量完成情况无显著差异。据患者自述,294例患者成功完成了SBPM。18例失败(6例报告设备故障,2例未理解操作流程,5例忘记,5例报告其他原因),50例未作答。这些结果表明,在REVEIL研究的实际条件下(医疗处方后免费租用设备),SBPM具有相当的适用性,因为85%的患者提供了有价值的信息,其中79%的信息质量良好。

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